Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method

ABSTRACT

The invention is a transvaginal ultrasound probe having an attached echogenic needle that is useful in the treatment of uterine fibroids. The echogenic needle has an echogenic surface near its tip that allows the physician to visualize its location using ultrasound imaging. In one embodiment, the needle has an active electrode at its distal end. The active electrode supplies radio frequency energy to a fibroids causing necrosis of the targeted fibroid or by destroying the fibroid&#39;s vascular supply. The radio frequency needle preferably has a safety device that shuts-off energy if the needle punctures the uterine wall. In a second embodiment, the needle has a cryogen supply tube and cryogen supply. This embodiment destroys fibroid tissue by freezing it or its vascular supply when the tissue comes in contact with the needle&#39;s frozen distal end. The invention further includes the method of using the ultrasound probe with the attached needle.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. application Ser.No. 10/345,635, filed Jan. 16, 2003, which is hereby incorporated hereinin its entirety by reference.

BACKGROUND OF THE INVENTION

This invention relates to surgical needles for tissue ablation, and moreparticularly, to surgical needles that are for ablation of uterinefibroids.

Approximately 20 to 40 percent of women have uterine fibroids(lieomyomata). In the United States, fibroids result in approximately175,000 hysterectomies and 20,000 myomectomies each year. Fibroids arewell-defined, non-cancerous tumors that arise from the smooth musclelayer of the uterus. Approximately 25% of women suffer fibroid relatedsymptoms, including menorrhagia (prolonged or heavy menstrual bleeding),pelvic pressure or pain, and reproductive dysfunction.

The most common treatments for fibroids include hysterectomy, abdominalmyomectomy, laparoscopic myomectomy, hysteroscopic myomectomy,laparoscopy-directed needle mylosis, laparoscopy-directed needlecryomyolysis, high-intensity focused ultrasound ablation of fibroids,and uterine artery embolization. Hysterectomy is a major surgicalprocedure and carries with it the usual risk of surgery, such ashemorrhaging, lesions, complications, pain, and prolonged recovery. Themajority of myomectomies are performed abdominally, wherein a surgeoncreates an abdominal incision through which individual fibroids areremoved. Abdominal myomectomy and laparoscopic myomectomy, like ahysterectomy, carries the usual risk of surgery.

Radio Frequency (RF) myolysis and thermal tissue ablation are twopromising methods for treating fibroids. RF myolysis is a technique inwhich a RF probe is inserted into a fibroid or the surrounding tissueand then RF energy is applied to the tip of the probe. The tissuesurrounding the tip is heated by the RF energy causing necrosis withinthe tissue. Thermal tissue ablation is a technique that is performedwith a cryoablation probe. The cryoablation probe destroys the fibroidtissue by freezing it.

Current methods incorporating RF or cryoablation techniques requiredirect visualization of the needle tip or electronic imaging. Normally,under direct visualization techniques an endoscope is inserted into theuterus to position the needle. Direct visualization is often problematicbecause of the difficulties involved in simultaneously manipulating theendoscope and needle. Typically, when electronic imaging is used, theposition of the needle is visualized with a hysteroscope or with anexternal abdominal ultrasound. Hysteroscopy allows direct visualizationof the uterine cavity by inserting a small camera on the end of a longtube directly into the uterus through the vagina and cervix. Similar toan endoscope, a hysteroscope must be simultaneously manipulated with theneedle, and thus is problematic. Monitoring the probe's position withcurrent ultrasound techniques has a number of drawbacks. For example, aclinician using ultrasound imaging from an external source will havedifficulty in distinguishing the uterine tissue from the surroundingorgans and precisely locating the needle.

U.S. Pat. No. 5,979,453 to Savage et al. describes a myolysis needlethat requires laparoscopic surgery. In laparoscopic surgery the needlemust be placed through the uterine serosa into or near the fibroid. As aresult, uterine adhesions often form that may cause chronic pain,infertility, and bowel obstruction. Additionally, during laparoscopicsurgery the surgeon cannot visualize the tissue below the surface andmust blindly place the needle, as a result placement may be sub-optimal.

U.S. Pat. No. 6,146,378 to Mikus et al. discloses a needle placementguide having an endoscope that is inserted into the uterus through thevagina. Using the endoscope, the surgeon positions the endoscopic guidein the correct orientation to the targeted fibroid. After positioningthe guide, the endoscope is removed from within the guide and anablation device is inserted into the guide for subsequent operation onthe fibroid. The needle guide suffers from several disadvantages. Thereis the risk that the needle guide could shift during removal of theendoscope and insertion of the ablation device, resulting in sub-optimalperformance. The needle cannot be relocated during the ablationprocedure and the endoscope must be reinserted whenever it is necessaryto reposition the needle guide. Reinserting and removing the endoscopeand ablation device every time the needle must be repositioned increasesthe time and expense of the surgery.

U.S. Pat. No. 6,379,348 to Onik describes a mylolysis needle that is acombination of a cryosurgical and electrosurgical instrument for tissueablation. The cryo/electro needle is not easily visualized when in useand requires the use of a dilator to create an access channel in thetissue area where the needle is to be inserted. Similar to laparscopicsurgery, placement of the cryo/electro needle is done blindly and maynot result in optimal performance.

Thus, a need exists to provide a medical needle system and method thatcan provide accurate and reliable targeting of fibroid tumors. It isalso desirable to provide a needle that has a safety system that wouldshut-off electrical current to the needle if the uterine wall ispunctured.

BRIEF SUMMARY OF THE INVENTION

The invention provides a medical needle for transvaginal ultrasounddirected reduction of fibroids. The medical needle is adapted for use inconjunction with a transvaginal ultrasound probe. The ultrasound probehas an attached needle guide through which the needle is inserted. Theneedle has an outer tubular member having an inner surface, a distalend, and a proximal end. The distal end of the outer member is made ofan echogenic material so that the tip of the needle has heightenedvisibility on an ultrasound screen. Located at the distal end is anactive electrode that is in communication with a radiofrequency source.An insulating sheath surrounds the entire outer member except for asection that is near the active electrode at the distal end.

The needle has a return electrode that is optionally located on theouter member near the active electrode or on an outer tissue surface ofa patient. Optionally, the needle may have a temperature sensor that islocated near the active electrode. Typically, the distal end will eitherbe a sharpened pointed tip or a beveled tip that defines an opening inthe distal end.

In a preferred embodiment, the needle has a safety device that will turnoff power to the active electrode if the tip of the needle shouldpenetrate a patient's uterine wall. In the embodiment possessing abeveled tip, an inner cylindrical member having a forward end and bluntrear end is disposed within the outer member. The inner member has acylindrical outer section that is electrically conductive and a sectionthat is not electrically conductive. Disposed on the inner surface ofthe outer member is a second electrically conductive surface and a thirdelectrically conductive surface that are not in communication with oneanother. The second surface is in communication with the RF power sourceand the third surface is in communication with active electrode.

A spring is attached to the forward end of the inner member and theblunt rear end extends outwardly beyond the beveled tip. When pressureis applied to the blunt rear end the spring is compressed and theexposed blunt rear end slides backwardly into the outer member. As theinner tubular member slides into the outer member the electricallyconductive surface comes in contact with both the second and thirdsurface so that current passes through the surfaces and RF energy issupplied to the active electrode.

In a second embodiment having a safety device, the inner tubular memberdoes not have a conductive surface and there are no second and thirdconductive surfaces. Rather, a switch is located at the proximal end ofthe outer member. When pressure is applied to the blunt rear end of theinner member, the inner member slides back into the outer member andthereby closes the switch. When in the closed position, the switch sendsa signal to the RF source and RF energy is applied to the activeelectrode.

In a third embodiment, the needle has an outer member, an inner surface,an echogenic distal end, and a proximal end. As in the first embodiment,the echogenic material results in the tip of the needle having aheightened visibility. Within the outer member is a cryogen tube thatextends longitudinally from the proximal end to the distal end.Surrounding a section of the outer member from the proximal end to nearthe distal end is a cryo-insulation sheath. The distal end is incommunication with a cryogen supply so that the distal end can be incryogenic contact with fibroids.

The length of the needle in all embodiments is typically from about 25to 50 centimeters, and somewhat more typically between 30 to 40centimeters. The diameter of the needle in all embodiments is typicallyfrom about 12 to 18 gauge, and somewhat more typically from about 16 to18 gauge. Normally, the needle has a handle at the proximal end thatallows the user to easily grip and manipulate the needle.

The invention also includes a method for the electric surgery offibroids using a transvaginal ultrasound directed echogenic needle. Themethod comprises the steps of providing a transvaginal ultrasound probehaving a transducer and attached needle guide; providing an echogenicneedle as described above; inserting the probe into a patient's uterus;inserting the needle into the uterus through the attached needle guide;sensing the location of the needle and fibroid using ultrasound imaging;guiding and positioning the needle on the surface of a fibroid usingultrasound imaging; and passing a controlled amount of RF energy throughthe fibroid. The method optionally includes the steps of monitoringtissue temperature, penetrating the surface of the fibroid with thedistal end of the needle, and the step of turning off power to theactive electrode if the distal end pierces the uterine wall.

The invention additionally includes the method for the cryoablation offibroids in the uterus using a transvaginal ultrasound directedechogenic needle. The method includes the steps of providing atransvaginal ultrasound probe having a transducer and an attached needleguide; providing a cryoablation echogenic needle as described above;inserting the probe into the uterus; inserting the echogenic needle intothe uterus through the attached needle guide; sensing the location ofthe needle and fibroid using ultrasound imaging; guiding and positioningthe needle on the surface of a fibroid using ultrasound imaging;delivering a controlled amount of cryogenic supply to the distal end ofthe needle while it in contact with the surface of the fibroid. Themethod optionally includes the step of penetrating the fibroid with thedistal end of the needle before or after delivering a controlled amountof cryogenic supply.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily drawn toscale, and wherein:

FIG. 1 is a side view of a transvaginal ultrasound probe having anattached echogenic needle that has been inserted into a uterus;

FIG. 2 is a perspective view of an ultrasound monitor displaying anechogenic needle that has been inserted into a uterus;

FIG. 3 is a side view of a radio frequency echogenic needle system foruse with a transvaginal ultrasound probe;

FIG. 4 is a sectional side view of the needle shown in FIG. 2;

FIG. 5 is a sectional side view of a radio frequency echogenic needlehaving a “shut-off” mechanism;

FIG. 6 is a sectional side view of a radio frequency echogenic needlehaving a “shut-off” mechanism and a noninsulated segment that is anactive electrode;

FIG. 7 is a sectional side view of a radio frequency echogenic needlehaving a “shut-off” mechanism and an active electrode disposed proximalto the distal end;

FIG. 8 is a sectional side view of a radio frequency echogenic needlehaving a “shut-off” mechanism and an active electrode disposed in theinner member;

FIG. 9 is a sectional side view of a radio frequency echogenic needlehaving a switch “shut-off” mechanism;

FIG. 10 is a sectional side view of a cryogenic ablation echogenicneedle; and

FIG. 11 is a side view of a radio frequency echogenic needle having areturn electrode attached to a patient's thigh.

DETAILED DESCRIPTION OF THE INVENTION

The present inventions now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the invention are shown. Indeed, these inventions may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

Referring more specifically to the drawings, for purposes ofillustration, but not of limitation, there is shown in FIG. 1 anembodiment of the invention referred to generally as 10. FIG. 1illustrates an ultrasound probe 100 having the attached mylosis needle105 that is inserted into the uterus 15. The ultrasound probe has atransducer located within its tip 30 so that imaging of the uterus andneedle are sent to a display for monitoring. Normally, the ultrasoundprobe 100 includes clamps 35 that attach the needle to the ultrasoundprobe. Typically, the clamps are made from a metal or plastic materialthat fits tightly around the probe and has an attached needle guide. Theneedle guide is typically a narrow or circular opening through which theneedle is inserted. Alternatively, the material comprising the clamps issome other hard material that allows the user to manipulate the needle,although not necessarily with equivalent results. The ultrasound probeuseful in the invention is any probe that is designed for insertionthrough the vagina.

As illustrated in FIGS. 1 and 2, the ultrasound probe 100 is insertedinto the uterus through the vagina. Once the probe is in place, theneedle is inserted through the needle guide and into the uterus. Thephysician uses ultrasound imagery to locate the position of fibroids 50and the needle 105 in the uterus. The tip of the needle 160 is directedagainst a targeted fibroid or its vascular supply and RF energy,cryogenic, or thermal treatment is applied to the fibroid to causenecrosis of the tissue. In this regard, FIG. 2 illustrates an ultrasoundmonitor 60 that is displaying ultrasound imaging of an echogenic needle105 that has been inserted into a uterus 15. Normally, the probe sendsdata to an ultrasound unit 65 that processes the data and then displaysthe resulting images on the monitor.

In all embodiments, the needle will have an echogenic surface 135 at ornear the distal end 120. For example, FIG. 3 shows a bumpy or unevensurface 135 on the outer member. Echogenicity refers to a surface'sability to reflect incident ultrasound waves back to a sensor. The morea surface reflects waves back to the sensor the greater its image willappear on an ultrasound display. Today, there is a variety of differenttechniques to increase a surface's echogenicity, including grooves orrecesses, bumps, coatings, indentations, and the like. In the invention,the echogenic tip enhances its visualization and helps the physician tomore precisely position the tip. Normally, the distal end of the needleor a segment proximal to the distal end will have an echogenic surface.

Inserting both the ultrasound probe and echogenic needle into the uterusthrough the vagina is very advantageous. Traditional laparoscopicmyomectomy requires that the ablation needle be inserted into the uterusthrough the abdomen. During this procedure the needle must be insertedthrough the uterine serosa, which may result in the formation of uterineadhesions. In contrast, the invention provides an apparatus and methodof use for fibroid myomectomy that is a minimally invasive surgicalprocedure. Adhesions are not expected to form with this method becausethe echogenic needle is inserted through the vagina rather thanpenetrating the uterine serosa. A second advantage of the invention isprecision and accuracy. The echogenic needle has a heightened ultrasonicvisibility that allows the physician to accurately locate and positionthe needle within the uterus. As a result, the surgical procedure isperformed more quickly, the needle is easily repositionable by thesurgeon, and most importantly the procedure will have a greaterbeneficial impact for the patient.

With reference to FIGS. 3 through 10, needles that are useful in thecurrent invention are illustrated. The needle has an outer tubularmember 115, a proximal end 125, a distal end 120, an insulation sheath200 surrounding a portion of the outer member, and an echogenic surface135 near the distal end.

As shown in FIG. 3, a RF needle is broadly designated by referencenumber 105. The needle 105 includes an active electrode at the distalend 120. Typically, the active electrode is a wire, wire loop, metalsurface, or the like. The active electrode is in communication with anelectrical connector 140 that is attached to the proximal end 125. Theelectrical connector 140 is connected to a RF power supply 140 a so thatRF current is supplied to the active electrode. The needle 105 isconnected to a RF power source 140 a, and optionally to a temperaturedisplay (heat readout) 140 b. Normally, the RF source will also includea means for controlling current to the active electrode 140 c.Typically, the RF needles will have a RF insulated sheath 200 thatsurrounds the outer member 115 and extends from the proximal end 125 tothe distal end 120 leaving a segment of the outer member 120 a (FIGS. 6and 7) that is RF noninsulated. The RF insulation sheath may be made ofany material that is suitable to prevent RF energy passing from theouter member to the tissue being treated, such as a heat shrinkpolyolefin or Teflon®.

The RF needle of the invention delivers either monopolar or bipolarcurrent. With reference to FIGS. 4 through 9, a RF needle having areturn electrode 210 is illustrated. The return electrode is connectedto the power supply so that current passes through the active electrodeinto the fibroid tissue and back to the return electrode. Normally, thereturn electrode is located on the outer shaft 115 about 2 to 20millimeters from the active electrode. Typically, the return electrode210 is positioned in close proximity to the active electrode so that RFenergy that passes from the active electrode through the fibroid isfocused and does not dissipate within the uterus. Alternatively, asillustrated in FIG. 11, the return electrode 210 a is located on anouter surface of the patient, such as the thigh or lower back. In thismanner, current passes out of the active electrode 175 through thepatient's tissue, and into the return electrode 210 a.

In FIG. 4, the active electrode 175 is depicted at the distal end 120within the needle. In this first embodiment, the distal end'snoninsulated outer surface 150 is electrically conductive so that RFenergy passes from the active electrode 175 into fibroid tissue. Thedistal end 120 has a sharpened tip 160 that can penetrate fibroid tissueto deliver RF energy within the fibroid. As shown in FIG. 4, the RFneedle optionally has a temperature sensor 185 disposed near the distalend 120. Typically, the temperature sensor will be disposed near the tipof the needle or within the insulation sheath. Normally, the temperaturesensor is a thermocouple or thermistor. The sensor provides informationthat enables the physician to monitor tissue temperature and to adjustthe power accordingly.

With reference to FIGS. 5 through 9, reference number 400 broadlydesignates a RF needle having a RF energy “shut-off” mechanism. Theshut-off mechanism turns off RF energy to the active electrode if thetip of the needle 190 penetrates through the uterine wall. Shutting offpower to the active electrode serves several useful purposes. Itprevents damage to healthy tissue, which would otherwise be coagulatedby RF energy and it alerts the physician that the needle has puncturedthe uterine wall.

In contrast to the first embodiment, RF needle 400 has a sharpenedbeveled tip 190, an inner cylindrical member 405, and a spring 430disposed within the outer member 115 at the outer member's proximal end125. The inner member 405 is disposed and moveable longitudinally withinthe outer member 115. As illustrated in FIGS. 5 through 9, the innermember 405 has a forward end 407 and a blunt rear end 425. The forwardend 407 is attached to the spring 430 that is connected to the needle'sproximal end 125. In the at rest position, the blunt rear end 425extends outwardly from the beveled tip 190 and is the first part of thedistal end 120 to contact uterine tissue. Applying pressure to the bluntrear end 425 compresses the spring 430, and the inner member 405 slideslongitudinally from the distal end 120 towards the proximal end 125. Asa result, the blunt rear end 425 retracts into the outer member 115 andthe beveled tip 190 contacts the surface of the targeted tissue.

In a first embodiment of RF needle 400, a segment of the innercylindrical member has a cylindrical conductive surface, and outermember 115 has a second and third conductive surfaces on its innersurface. The second surface is in communication with the RF power supply140, and the third surface is in communication with the active electrode175. When in the rest position, the second and third surfaces are not incommunication with each other. As pressure is applied to the blunt rearend 425 the inner member 405 retracts into a charged position. When in acharged position, the conductive surfaces 410, 415, and 420 are incommunication and RF energy flows from the RF power source to the activeelectrode. If the distal end 120 punctures the uterine wall pressureagainst the blunt rear end 425 will be released and the spring 430 willrapidly extend the blunt rear end 425 outwardly. As a result, theconductive surface 410 will move longitudinally away from the second andthird surfaces 415, 420 and RF energy supplied to the active electrodeis shut-off. The exact position of conductive surfaces 410, 415, and 420is not critical except that it is necessary that all three surfacessimultaneously communicate with each other when the inner member is in aretracted position.

In this regard, FIG. 6 shows a conductive surface 410 on the innermember 405. The conductive surface 410 is optionally located at theforward end 407 of the inner member 405 or at almost any position alongthe inner member. The second 420 and third surfaces 415 are located onan inner surface 117 of the outer member 115 so that when the innermember 405 retracts the conductive surfaces 410, 415, and 420 contacteach other. When pressure is applied to the blunt rear end 425, thespring 430 compresses and the inner member retracts into the outermember 115. As a result, the conductive surfaces 410, 415, and 420 arein communication with one another and RF energy is delivered to theactive electrode 175.

The active electrode is at the distal end 120 or alternatively, thenoninsulated surface 120 a of the outer member 115 is the activeelectrode. In this regard, FIG. 7 illustrates an RF needle having aninsulation sheath 435 disposed between the second conductive surface 420and the outer member 115. RF energy is supplied to the second surfacethrough a current line 440 that is in communication with the electricalconnector 140. As shown in FIG. 7, conductive surface 410 on the innermember 405 is in electrical communication with the outer member's 115inner surface 117. Typically, the outer member is made from a material,such as stainless steel, that is electrically conductive and suitablefor insertion into tissue. When the inner member 405 retracts into theouter member 115 the second surface 420 contacts the conductive surface410 supplying RF energy to the noninsulated segment 120 a. Optionally,insulation sheath 435 insulates the entire inner surface 117 of theouter member 115 except for segments at the active electrode 120 a andthe third conductive surface 415.

In a second embodiment of a needle having a safety mechanism 400, theactive electrode is located at the blunt rear end. As shown in FIG. 8,the active electrode 175 is located at the blunt rear end 425 and anelectrical connector 425 a extends longitudinally from the conductivesurface 410 to the active electrode 175. The outer member 115 has asecond conductive surface 420 that is in communication with RF powersupply, but rather than having a third surface in communication with theactive electrode, the conductive surface 410 on the inner member 405 isin communication with the active electrode 175. When pressure is appliedto the blunt rear end 425, the spring 430 compresses and the innermember retracts into the outer member. As a result, the conductivesurfaces 410, 415 contact one another and RF current is applied to theactive electrode 175. Typically, the electrical connector 425 a isdisposed within the inner member 405.

However, the electrical connector 425 a may be disposed between thesurface of the inner member and an optional RF insulation sheath thatsurrounds the inner member. The optional insulation sheath does notsurround the conductive surface 410 or the active electrode 175.

In a third embodiment of a RF needle with a safety mechanism 400, theinner member is connected to a switch. With reference to FIG. 9, aneedle is shown having an inner member 405 attached to a switch 450. Theswitch 450 is in communication with a RF power source via line 455. Aspressure is applied to the blunt rear end 425 the inner member 405retracts into the outer member 115 and closes the switch 450. When inthe closed position, the switch 450 sends an electrical signal throughline 455 to the RF power supply 140 a and RF energy is delivered to theactive electrode. The active electrode is located at the distal end andis in communication with the switch, or alternatively, the noninsulateddistal end 120 a is the active electrode.

In all the embodiments of a needle having a safety mechanism 400 theinner member 405 is typically made from a material that isnon-conductive, such as a plastic. Normally, a non-conductive memberwill have a conductive material, such as stainless steel, inserted intoa surface segment so that the inner member has an electricallyconductive surface that will contact the second and third surfaces onthe outer member. Somewhat more typically, the inner member is made froma metal such as stainless steel that is surrounded by a RF insulationsheath. The insulation sheath surrounds the inner member except for theconductive surface 410, which is RF non-insulated.

With reference to FIG. 10, a cryoablation needle is broadly illustratedby reference number 500. The cryoablation needle has an echogenic distalend having a sharpened tip 160. The outer member 115 is surrounded by acryo-insulation sheath 200 a. The insulation sheath 200 a extendslongitudinally from the proximal end 125 to the distal end 120 leaving asegment of the outer member 120 a that is cryo-noninsulated. Normally,the sheath will be made of any material that prevents the cryogeniceffect from passing through the outer member and into the surroundingtissue. A cryogen supply tube 510 is disposed within the outer memberand extends from the proximal end 125 to the distal end 120. A cryogensupply source 520 provides cryogen supply through a cryogen connector525 to the cryogen supply tube 510.

Typically, cryogenic liquids such as nitrogen, helium and argon are usedto produce the cryogenic effect in the targeted tissue.

In all embodiments, it is necessary that the needle is longer than theultrasound probe and has sufficient length to reach fibroids deep in theuterus. Typically, the length of the needle is about 25 to 50centimeters, and somewhat more typically about 30 to 40 centimeters. Theneedle's diameter is dictated by the ultrasound probe's attached needleguide. Typically, the diameter of the needle is about 12 to 18 gauge,and somewhat more typically about 16 to 18 gauge. However, the needle isnot limited to the above recited dimensions and may be varied dependingupon the actual length of the probe and the needle guide's innerdiameter. Typically, the outer member is made of any material that issuitable for insertion into tissue, such as stainless steel.

Optionally, as shown in FIG. 3, the needle will have a handle 130 at itsproximal end 125. The handle 130 allows the user to easily manipulateand move the tip of the needle. Ideally, the handle 130 is large enoughto be manipulated with the user's thumb, index finger and middle finger.Normally, the handle is metal, plastic, rubber, or the like.

Many modifications and other embodiments of the inventions set forthherein will come to mind to one skilled in the art to which theseinventions pertain having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the inventions are not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims.Although specific terms are employed herein, they are used in a genericand descriptive sense only and not for purposes of limitation.

1. An echogenic medical needle comprising: a tubular outer member havinga distal end and proximal end, said tubular outer member beingpositionable into a needle guide that is attached to a vaginalultrasonic probe; an echogenic surface disposed proximal to said distalend; a cryo-insulation sheath disposed on said outer tubular member anddefining a distal segment of said outer member that is cryo-noninsulatedso that said distal end can be placed in cryogenic contact with uterinefibroids; and a cryogen supply tube extending from said proximal end tosaid distal end through which a cryogenic supply is provided to saiddistal end.
 2. The medical needle according to claim 1, furthercomprising a cryogen supply that is in communication with said tubewhereby said cryogen supply is delivered to said distal end.
 3. Themedical needle according to claim 2, wherein said cryogen supplycomprises a cryogenic liquid.
 4. The medical needle according to claim1, wherein said cryogen supply tube is disposed in an interior of saidtubular outer member.
 5. The medical needle according to claim 1,wherein the echogenic surface comprises one or more of grooves,recesses, bumps, indentations, or coatings formed on the surface of saidtubular outer member proximal to said distal end.
 6. The medical needleaccording to claim 1, wherein said distal end further comprises asharpened point for penetrating tissue.
 7. The medical needle accordingto claim 1, wherein said cryo-noninsulated segment is capable ofproducing a cryogenic effect in targeted tissue.
 8. An echogenic medicalneedle for transvaginal ultrasound directed cryoablation of uterinemyomas and fibroids comprising: a tubular outer member having an innersurface, a distal end having an echogenic surface, and a proximal end; acryo-insulation sheath surrounding a surface of a segment of said outermember, said cryo-insulated segment extending from said proximal end ofsaid outer member to, but not including, said distal end of said outermember, such that said distal end can be placed in cryogenic contactwith uterine fibroids; a cryogen supply tube extending from saidproximal end of said outer member to said distal end of said outermember; and a vaginal ultrasonic probe having an attached needle guidewhereby said medical needle is positionable in said needle guide.
 9. Themedical needle according to claim 8, further comprising a cryogen supplythat is in communication with said tube whereby said cryogen supply isdelivered to said distal end of said outer member;
 10. The medicalneedle according to claim 8, wherein said distal end further comprises asharpened point for penetrating tissue.
 11. The medical needle accordingto claim 8, wherein the length of said outer member is about 25-50centimeters.
 12. The medical needle according to claim 8, wherein thelength of said outer member is about 30 to 40 centimeters.
 13. Themedical needle according to claim 8, wherein the diameter of said outermember is about 12-18 gauge.
 14. The medical needle according to claim8, wherein the diameter of said outer member is about 16-18 gauge. 15.The medical needle according to claim 8, wherein said proximal endfurther comprises a finger grip for manually directing said distal end.16. The medical needle according to claim 8, wherein said attachedneedle guide is a plastic or metal clamp fitted around said probe andhaving an opening through which the needle is insertable.
 17. Themedical needle according to claim 8, wherein the echogenic surfacecomprises one or more of grooves, recesses, bumps, indentations, orcoatings formed on the surface of said tubular outer member proximal tosaid distal end.
 18. A method for the cryoablation of myomas andfibroids in the uterus using a transvaginal ultrasound directedechogenic medical needle comprising the steps of: a) providing anultrasound probe having a transducer and a needle guide attached to saidprobe; b) providing an echogenic needle, the echogenic needle includinga tubular outer member having a distal end having a echogenic surface, aproximal end, a cryo-insulation sheath surrounding a surface of asegment of said outer member, said cryo-insulated segment extending fromsaid proximal end of said outer member to, but not including, saiddistal end of said outer member, a cryogen supply tube within said outermember, said tube extending from send proximal end of said outer memberto said distal end of said outer member, and a cryogen supply that is incommunication with said tube whereby said cryogen supply is delivered tosaid distal end of said outer member; c) inserting said ultrasound probeinto a uterus; d) inserting said echogenic needle into said uterusthrough said needle guide; e) sensing the location of said fibroids andsaid echogenic needle within said uterus with said ultrasonic probe; f)guiding said echogenic needle to a surface of said fibroids using theultrasound imaging; g) positioning said echogenic needle on said surfaceof said fibroid; and h) delivering a controlled amount of said cryogensupply to the surface of said myoma to cause cryoablation of saidfibroid.
 19. The method according to claim 18, wherein the step ofpositioning the echogenic needle in contact with said fibroid furtherincludes the step of penetrating said surface with said distal end ofsaid echogenic needle.
 20. The method according to claim 18, wherein thestep of positioning the echogenic needle in contact with said fibroidfurther includes the step of positioning the echogenic needle in contactwith the fibroid's vascular supply.